Heparin Lawyer | Heparin Deaths

With Special Packaging, Sagent Gets FDA Approval For Heparin Products

Posted on 6th July 2010 by gjohnson in Uncategorized

Dennis Quaid, Dennis Quaid heparin lawsuit, heparin, heparin attorney, heparin lawyer, heparin overdose

In a much publicized case, actor Dennis Quaid’s newborn twins were accidentally given heparin overdoses in 2007. He blames the packaging of the drug for the mishap, with 10,000 unit and 10 unit heparin vials looking so similar that nurses confused them.

Well, a heparin manufacturer has addressed that issue, and Tuesday asserted that its special labeling — with different colors for each strength of heparin – helped it to win Food and Drug Administration approval for nine of its heparin products.
http://www.fiercepharmamanufacturing.com/story/packaging-contributes-approvals-sagents-heparin/2010-07-06

Sagent said it will launch its new heparin products, the heparin sodium injection USP, immediately. In 2009 U.S. sales of heparin were about 306 million.
http://www.pharmabiz.com/article/detnews.asp?articleid=56257&sectionid=

“Attaining FDA approval of Sagent’s heparin vials is a major accomplishment for our company,” CEO Jeffrey Yordon said in a prepared statement. “Amidst the many challenges the nation’s supply of heparin has recently faced, Sagent identified and readied a reliable source for heparin and successfully navigated the FDA approval process for each of our heparin presentations. We believe that our innovative approach to the packaging and labelling of our heparin provides us with a significant advantage in the market by better meeting the requirements of patients and customers, positioning us for a successful launch.”

Sagent’s has proprietary PreventIV Measures packaging and labeling, which aids users in distinguishing between the nine presentations. Sagent’s packaging and labeling for heparin include using of a unique colour for each total strength; easy-to-read drug name, concentration and fill volumes; and cartons printed on all sides.

PreventIV Measures is Sagent’s name for what it calls its user-driven and patient-centered approach to product labeling and packaging, which considers everyone handling medication along the way in order to help prevent medication errors.

“The pace of hospital care is faster than it has ever been, requiring increased vigilance to reduce treatment errors,” Elaine Levy, system director for Pharmacy Sharp HealthCare in San Diego, California, said in a prepared statement.

“Sagent’s PreventIV Measures approach to packaging and labeling design makes it easier to differentiate drugs from others in the same class, even when the medications look or sound alike,” she said. “Further, it makes it easier to distinguish between doses, which is especially important when working with medications like heparin that have a number of concentrations and sizes. I believe that features such as those incorporated into Sagent’s products can help reduce those errors caused by selecting the incorrect medication for a patient.”

PreventIV Measures is Sagent’s comprehensive, user-driven and patient-centred approach to product labelling and packaging that is designed to help prevent medication errors. It incorporates unique label and carton designs, cap and label colours, bar coding and other features that are designed to make it easier to differentiate drugs and identify the correct dose.

Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.

http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
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Patient-Safety Advocate Dennis Quaid Finds Staunch Supporter In Iowa Congressman Bruce Braley

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Posted on 27th April 2010 by gjohnson in Uncategorized

Cedars-Sinai Medical Center, Dennis Quaid, Federal Drug Administration, heparin lawyer, heparin overdoses, patient safety, Rep. Bruce Braley

Actor Dennis Quaid, a crusader for patient-safety improvements after his twins were almost killed by an accidental heparin overdose, has found an ally in U.S. Rep. Bruce Braley, D-Iowa. http://www.brucebraley.com/free_details.asp?id=1

Braley, who spent 23 years as a trial attorney before turning to politics and going to Congress, participated in the first Oversight and Government Reform hearing where Quaid testified about his newborn twins being given near-fatal heparin overdoses at Cedars-Sinai Medical Center in Los Angeles in 2007. http://www.brucebraley.com/free_details.asp?id=39

If life-and-death issues weren’t at stake here, it would almost be amusing to watch a Federal Drug Administration official squirm as Braley grilled him at the hearing. Braley impressed Quaid so much that at the end of the proceedings, the actor thanked the Iowa lawmaker and said he wished that the lawyer was his Congressman.

During the hearing, Quaid testified that drug companies shouldn’t have “immunity from any liability” – an argument that heparin manufacturer Baxter International is making — just because the drugs they sell have been approved by the FDA. Drug companies should be laughed out of court, the nation’s highest court in fact, for trying to make that argument.

The U.S. Supreme Court has in fact decided to hear a case regarding whether the law preempts suits being filed against drug companies, since their medications have FDA approval, Quaid noted during his testimony in Washington.

Quaid has been everywhere, not only D.C. but “The Oprah Winfrey Show” and medical conferences, to talk about his near-tragic experience and plead for safeguards to reduce potentially lethal medical mistakes. His twins are 2 ½ years now, and appear to be healthy despite their touch-and-go experience at Cedars-Sinai. But the problem regarding mistakes with heparin hasn’t been solved.

In a chat not long ago with The Wall Street Journal, Quaid cited a recent and well-publicized case where a toddler died of a heparin overdose caused by an infusion-pump setting mistake in a Nebraska hospital. http://blogs.wsj.com/health/2010/04/22/patient-safety-the-movie/tab/print/

Quaid had been scheduled to attend the recent world premiere of his documentary, “Chasing Zero: Winning the War on Healthcare Harm” at the International Forum on Quality and Safety in Health Care in Nice, France.

But then Quaid and Dr. Charles Denham, who was in charge of production of the documentary, couldn’t get to the screening because of the disruption of air travel due to the Icelandic volcano eruption, according to The Journal. Only 500 attendees made it, out of an expected crowd of 3,000, because of the travel disaster.

The documentary, which features Quaid, aired on Discovery Channel April 24 and will be repeated Saturday, May 1. After the documentary airs on TV, Denham and Quaid’s recently merged research foundation, TMIT, will hand out copies of it free to all 5,700 U.S. hospitals to spotlight the importance of adopting the safe practices developed by the National Quality Forum, which crafts voluntary safety rules for hospitals, according to The Journal.

There are an estimated 100,000 deaths each year from medical errors and another 100,000 deaths each year from hospital infections, many of then preventable, according to Quaid and his supporters, like Rep. Braley.

The exact number of these deaths is still unknown because a lot of states don’t have a standard or mandatory reporting system for injuries caused my medical mistakes, according to Scientific American magazine. http://www.scientificamerican.com/blog/60-second-science/post.cfm?id=deaths-from-avoidable-medical-error-2009-08-10

Let’s see if Rep. Braley helps Quaid make any headway in his quest for patient safety.

Tainted Drywall The Latest Scourge From China

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Posted on 6th April 2010 by gjohnson in Uncategorized

contaminated heparin, dangerous Chinese products, heparin, heparin lawyer

First, China brought us contaminated heparin. Now, it’s brought us drywall that is endangering American homeowners.

The federal government on Friday warned families with the defective drywall to take it out of their homes, because its noxious emissions are being linked to health and safety problems. http://online.wsj.com/article/SB10001424052702304871704575159971085212294.html?mod=WSJ_WSJ_US_News_5

The drywall, also called gypsum or wallboard, has been connected to electrical problems and causing respiratory problems for residents of new homes, mainly in Louisiana and Florida. http://www.nytimes.com/2010/04/03/business/03drywall.html?ref=business

Some Chinese-made drywall is emitting hydrogen sulfide at rates 100 times greater than non-Chinese drywall, according to information The Journal cited from the Consumer Product Safety Commission and Department of Housing and Urban Development.

The drywall came under federal investigation after homeowners complained about smelling rotten-egg like sulfide odors. But that’s not all. Homeowners complained that they were suddenly getting bloody noses, headaches and respiratory problems – and that some of their appliances were corroding.

More than 3,000 complaints have been filed with the Consumer Product Safety Commission from people who claim fumes from the drywall have damaged their homes, according to The Journal.

One consulting firm pegged the damage from the faulty drywall at $15 billion to $25 billion. The question now is who will foot the bill.

Some home builders are already fixing homes they built with the defective Chinese drywall. One company, Lennar Group, has budgeted $81 million to fix 600 homes it built in Florida, The Journal reported. Lennar wants to get that money back from insurers and subcontractors.

Heparin Rival Is In A Pickle Over Patent For Angiomax

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Posted on 19th March 2010 by gjohnson in Uncategorized

Angiomax screwup on patent, heparin, heparin attorney, heparin lawyer

The manufacturer of a rival blood-thinner to the generic heparin is trying to overcome what The New York Times Friday called “one of the costliest blunders in drug industry history.” http://www.nytimes.com/2010/03/19/business/19patent.html

The Times story, headlined “A Company Races to Keep a Drug Patent,” describes the predicament of Parsippany, N.J.-based Medicines Co., which makes the blood thinner Angiomax.

In a clerical error that should have cost someone his or her job, Medicines back in 2001 missed a deadline to apply for a patient extension for Angiomax. So now that patent is set to expire next Tuesday, instead of in December 2014. That means generic versions of the drug will be able to come to market.

The drug maker has filed several appeals with patent officials over its goof, unsuccessfully. But Tuesday a federal judge ruled that the U.S. Patent and Trademark Office must reconsider its denial of Medicines’ 2001 filing.

The Times’ story outlines all of Medicines’ machinations to retain its patent on Angiomax. And that includes a convoluted argument by Medicines’ about its blood thinner versus heparin.

The drug makers has studies that maintain that it would save the health care system billions of dollars over the next two decades if Angiomax retains its patent.

Medicines argues that a continued patent would mean more promotion for Angiomax, and possibly new uses for it, according to The Times. So its use would increase at the expense of its main competitor, generic heparin.

Yet Angiomax is much pricier than heparin, at more than $600 a patient, versus pennies for heparin.

“But Medicines argues that Angiomax is actually cheaper for the health care system overall than heparin, partly because it causes less bleeding, a serious and costly side effect,” The Times writes.

Heparin Debacle Lead To A Decline in Chinese Drug Exports

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Posted on 23rd February 2010 by gjohnson in Uncategorized

Baxter recall of heparin, contaminated heparin, heparin lawyer, heparin recall, heparin recall results in drop in Chinese Imports

China’s sometimes deadly quality control issues cut into the demand for its active pharmaceutical ingredients (API)s last year, but that will change this year, according to outsourcing consultant JZ Med.

The bean counter statistical analysis of this is really quite remarkable. From our perspective the decline should have been catastrophic, not single digits. It just goes to show how little this huge debacle for America’s most ill patients, has stayed out of the news cycle. By point of comparison, I wonder what the drop in Chinese dog food and drywall has been?

If the public had truly understood the magnitude of this disaster, the result might have been to ban all foreign manufacture of drugs. Perhaps when the full extent of the disaster is known because of the hundreds and hundreds of wrongful death cases still pending, the experts such as JZ Med will have to redo their numbers. We can only hope that the Civil Justice System can do more to protect us than Wall Street and the FDA has done.

The market for APIs from China last year dipped 3 percent, to be worth $31 billion, said FiercePharma, based on the report from JZ Med. http://www.fiercepharma.com/story/chinas-api-exports-hurt-quality-issues/2010-02-22

Chinese API exports declined by 8 percent, to about $16 billion last year. JZ Med believes these numbers declined because of quality control disasters like the 2008 recall of the blood thinner heparin from China, which was contaminated and was blamed four countless deaths. The world’s economic woes have also cut the demand for Chinese APIs. See http://heparin-law.com

JZ Med argues, and we are not necessarily buying into this, that drip in demand has made some API manufacturers to improve their quality control to be more in line with the standards in place in the United States and Europe.

This year the market for APIs will increase 5 percent to 8 percent, according to JZ Med, to $33 billion. Following that, the API growth should see larger annual increases, to 15 percent, or $65 billion, by 2015, the consultant said.

Please, Big Pharma: If I am sick and need something put directly into my veins so that I don’t die during a procedure, can you please make sure it comes from a facility that the FDA has inspected? The only way to really make sure is to have that facility to be directly under the FDA’s jurisdiction. In other words, in the USA.

Traceability And The Recalls of Deadly Heparin and Peanuts

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Posted on 11th February 2010 by gjohnson in Uncategorized

FDA recall heparin, heparin, heparin adverse reactions, heparin attorney, heparin lawyer, heparin traceability

Traceability, the ability of a manufacturer to track where it secured raw materials and where it shipped product, is a key issue in lawsuits regarding heparin, the tainted blood thinner that was recalled and is being blamed for causing countless U.S. deaths in 2007 and 2008. http://heparin-law.com

InTech Home, from the International Society of Automation, has a detailed analysis of the issue of traceability and suggests requirements for traceability systems. http://www.isa.org/InTechTemplate.cfm?Section=General_Information2&template;=/ContentManagement/ContentDisplay.cfm&ContentID;=81071

The article cites a number of pharmaceutical and food product recalls where traceability has been an issue, including heparin that came from China and had a deadly contaminant in it, allegedly killing people. The story also mentions two salmonella outbreaks: One caused by jalapeno peppers from Mexico, which sickened 1,442 people, in 2008; and the eight deaths, and sickening of more than 600 people, from foods containing tainted peanuts that same year.

“While the current U.S. Bioterrorism Act requires traceability known as ‘one up and one down,’ recent food scares such as contaminated peanuts and peppers have demonstrated true recalls and safety announcements multiple supplier cooperation,” the story says.

The article says traceability has to do with determining what lots went into a product, and that such “lot assignments are the norm in drug manufacturing.” Lawyers have a lot of questions for heparin makers about traceability and lots during litigation stemming from the deaths two years ago.

As for traceability standards, the story makes six suggestions for food products.

The story’s first recommendation for the food industry is to first create a system that identifies “all source component ingredients” of a product within seconds. The second is to enable tracing of any ingredient “to identify all associated products within seconds,” Third is to quickly implement the recommended practices. Fourth is to address public concerns about tracing products. Fifth is to create a low-cost, low-burden traceability system. Sixth is to support other industry safety initiatives.

Finally, the article calls for standard lot identification of food products, suggesting “a new universal 16-character code as a consistent method of identification.”

FDA Announces Weaker Heparin – Weaker than What?

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Posted on 2nd October 2009 by gjohnson in Uncategorized

anaphylactic heparin reaction, FDA, FDA announces new weaker heparin, FDA recall heparin, heparin attorney, heparin lawyer

Suddenly the FDA and the manufacturer’s of heparin are worried that perhaps the quantity of active ingredients in the heparin they sell might be a bit diluted. How ironic. See http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm184674.htm

Throughout what Congress called the “heparin catastrophe” millions of dosages of heparin weren’t diluted by 10%, but as much as 20%, not by harmless diluters, but by dangerous ingredients such as OSCS. See also the U.S. News story at http://health.usnews.com/articles/health/healthday/2009/10/01/us-health-officials-announce-new-heparin-formula.html

According to the U.S. News story:

The correct dosing of heparin has always been highly individualized and requires intense monitoring, which is a protocol that will remain in effect, officials said.

“The use of heparin is closely tied into monitoring and doses adjusted based on that,” said Dr. Dwaine Rieves, director of CDER’s Division of Medical Imaging and Hematology Products. “That procedure will not change.”

Now the FDA tells us that the correct dosing of heparin has always been highly individualized and requires intense monitoring? How could doctors have monitored heparin dosages when no one was monitoring how much active ingredient was in the product?

The litigation around heparin has swirled around a specific contaminant OSCS. Yet, there have been thousands of additional adverse reactions outside the recall time period, continuing up to this day.

Now it begins to become clear. If the manufacturer had no way to establish how pure the product was, how could “intense monitoring” have occurred? I believe the ultimate death toll from this drug will not just include OSCS poisoning, but complications because thousands more individuals didn’t and couldn’t get the right “intense monitoring” by their doctors.

Heparin Deaths – Moving the Case Towards Trial

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Posted on 10th September 2009 by gjohnson in Uncategorized

Baxter Heparin Wrongful Death case Illinois, heparin, heparin adverse reactions, heparin attorney, Heparin deaths, heparin lawyer

In our previous blog, we discussed the filing of more than 150 wrongful death cases against Baxter with respect to their sale and distribution of contaminated heparin in Cook County, Illinois. Today, we begin our discussion of the process those cases are going thru prior to trial. When a lawsuit is filed, it typically takes more than a year before it can be tried. Both sides have a right to put together their case and both sides have the right to find out what the other parties case is about. Deadlines are created for each side to name the expert witnesses upon which they will rely and to provide evidence to rebut the claims of the other side.

In addition, normally from very early on in the litigation, witnesses who have factual information about the events of what happened will be deposed. When the litigation is a complex as Baxter Heparin wrongful death litigation, things move slower than in an automobile accident case. The process of taking depositions and finding out what the other side is claiming, is called “discovery.”

The Illinois cases are currently in the stage of “discovery” after the court granted plaintiffs’ motion to strike all affirmative defenses alleged in their Answer by defendants Baxter International, Inc. and Baxter Healthcare Corporation (collectively “Baxter”). An affirmative defense is a claim by a defendant that even if all of the allegations against them are true, they still don’t have any responsibility for any number of technical reasons. The Court found that none of these technical claims protected Baxter from accountability here.

Plaintiffs have submitted to Baxter’s counsel their individual Plaintiff’s Fact Sheets in accordance with the judge’s orders, and defendants have been ordered to submit their own fact sheets in response to each case which has been filed against them. In addition, requests for production to and from the defendants (a form of written request that a party turn over documents) have been served and received. More than one million documents having been produced by defendants. Subpoenas for records have likewise been issued for all major Heparin drug distributors in order to establish the contaminated product’s chain of custody.

Oral depositions on key Baxter personnel are currently underway. On April 2, 2009, plaintiffs’ counsel took the deposition of Marie Keeley, Baxter’s Vice President for Business Operations, in order to gain a deeper understanding of Baxter’s existing sales and product distribution system. Other depositions scheduled involve Amy Gierytich and Tom Progar, Baxter employees who have been directly involved in handling Baxter’s first and second recall of Heparin products in January and February 2008, from recall strategy formulation and implementation to dealings with the Federal Food and Drug Authority and the Centers for Disease Control and Prevention. Baxter’s Vice President for Global Medical and Clinical Affairs, Francois Lebel, will also be deposed as well as Baxter’s designee of the person with greatest knowledge on causation.

In our next blog, we will discuss timing and future trial dates.

Wyeth shareholders vote to be acquired by Pfizer

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Posted on 20th July 2009 by gjohnson in Uncategorized

anaphylactic heparin reaction, FDA, FDA recall heparin, FDA recall of Heparin, heparin lawyer, Pfizer acquisition, Wyeth sale

Any lingering doubt that the drug companies are among the worst of Wallstreet’s culprits gets set aside when one large company gets swallowed up a enormous company. They may still have American sounding names, but the reality this is big business, looking out only for profits, with not even a passing glance at the American consumer and the American worker. If the FDA doesn’t get back in front of these companies soon, the drug industry might ultimately collapse because we won’t be able to trust these products enough to put them in our bodies.

Attorney Gordon Johnson
http://heparin-law.com
http://tbilaw.com

Date: 7/20/2009 10:15 AM

MADISON, N.J. (AP) — Shareholders of drugmaker Wyeth have voted overwhelmingly to be acquired by industry giant Pfizer Inc.

More than 98 percent of Wyeth stockholders voted to approve the $68 billion acquisition. The deal will solidify Pfizer’s position as the top-selling drug maker in the world.

For Pfizer, it transforms the company overnight from being primarily a maker of the blockbuster pills to a one-stop shop for medical treatments. That’s because Wyeth brings multibillion-dollar products and substantial expertise in researching and manufacturing biologic drugs, vaccines, nonprescription medicines and animal health products.

Wyeth’s shareholders cast their votes while gathered at their annual meeting at the company headquarters in Madison, N.J.

Copyright 2009 The Associated Press.

Merck and Schering Plough settle investigation

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Posted on 15th July 2009 by gjohnson in Uncategorized

anaphylactic heparin reaction, FDA, heparin, heparin attorney, heparin lawyer, Merck, Merck disclosure allegations, Vytorin, Zetia

Another case of large pharmaceutical in trouble with the FDA for improper disclosure. This time it is Merck and the drugs are Zetia and Vytorin. The legal settlement is for peanuts and is clearly being done to expedite a Wallstreet acquisition. But why is it that our drug companies continue to mislead?

Attorney Gordon Johnson
http://heparin-law.com
http://tbilaw.com

Date: 7/15/2009 5:23 PM

MARLEY SEAMAN,AP Health Writer

NEW YORK (AP) — Drugmakers Merck & Co. and Schering-Plough Corp. said Wednesday they will pay $5.4 million to settle a multistate investigation that the companies delayed the release of test results casting doubt on the effectiveness of two blockbuster cholesterol drugs.

The companies settled with attorneys general from 35 states and the District of Columbia. The investigation centered on allegations the companies kept quiet the results from an unfavorable study, violating consumer protection laws. Merck and Schering-Plough will pay back the costs of the investigation, but don’t have to make other payments or admit wrongdoing or liability.

In January 2008, the companies released study data showing Vytorin and Zetia, sold by the Merck/Schering-Plough Pharmaceuticals joint venture, were not more effective than an older, much-cheaper drug at reducing plaque buildup in the blood vessels of the neck. The testing was finished in 2006 and the companies faced criticism for not releasing the results sooner.

The study compared Zetia and Vytorin to Zocor, a drug that is one of Vytorin’s ingredients. Zocor is available as a low-cost generic drug. Later studies raised additional concerns about safety and effectiveness.

Kentucky Attorney General Jack Conway said the companies agreed to get advance Food and Drug Administration approval for all TV advertisements aimed at consumers and comply with FDA suggestions to modify that advertising. Additionally, the companies will register clinical trials and report results and agreed to comply with rules barring the deceptive use of those trials, avoid ghost writing of articles by physicians, and reduce conflicts of interest on boards monitoring clinical trials.

The state of Kentucky — where the agreement was filed — will receive $100,000 in the settlement.

Merck, of Whitehouse Station, N.J., and Schering-Plough, based in Kenilworth, N.J., said they will continue to comply with laws requiring the truthful and non-misleading marketing of their drugs. A study published in the New England Journal of Medicine showed Merck and Schering-Plough spent $200 million to market Vytorin and Zetia to consumers in 2007.

“We think this agreement is consistent with what we’ve said and what we believe, which is that the company conducted the ENHANCE trial in good faith and that our promotion of Zetia and Vytorin were in compliance with the law,” said Merck spokesman Ron Rogers.

Rogers said settling for legal costs was in the best interest of all concerned and lets Merck and Schering-Plough remain focused on creating new medicines and vaccines.

The settlement does not resolve all the lawsuits and investigations involving the drugs, however. In a May regulatory filing, Merck disclosed that subcommittees from the U.S. Senate and House of Representatives have asked the company and Schering-Plough to interview employees and examine documents related to Zetia and Vytorin. Merck also disclosed that the Justice Department is investigating the companies’ conduct in selling the drugs, and the possibility that they may have submitted false claims to federal health care programs as they promoted Vytorin.

Merck said it was then aware of 145 civil class action lawsuits related to the drugs.

The 35 states involved in Wednesday’s settlement are Arizona, Arkansas, California, Colorado, Delaware, Florida, Hawaii, Idaho, Illinois, Iowa, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia, and Wisconsin.

Merck is in the process of buying Schering-Plough for $41.1 billion. Merck shares rose 55 cents, or 2 percent, to close at $27.71. Schering-Plough stock added 45 cents, or 1.8 percent, to $25.37.

Copyright 2009 The Associated Press.

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With Special Packaging, Sagent Gets FDA Approval For Heparin Products

Patient-Safety Advocate Dennis Quaid Finds Staunch Supporter In Iowa Congressman Bruce Braley

Tainted Drywall The Latest Scourge From China

Heparin Rival Is In A Pickle Over Patent For Angiomax

Heparin Debacle Lead To A Decline in Chinese Drug Exports

Traceability And The Recalls of Deadly Heparin and Peanuts

FDA Announces Weaker Heparin – Weaker than What?

Heparin Deaths – Moving the Case Towards Trial

Wyeth shareholders vote to be acquired by Pfizer

Merck and Schering Plough settle investigation

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